NCT02416570

Brief Summary

This study aims to identify if clarithromycin (CLM) has potential as a widely available and inexpensive treatment for cachexia (the loss of muscle mass) in people with non-small cell lung cancer (NSCLC). Half the participants will receive clarithromycin and half will receive a placebo.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

6 months

First QC Date

March 6, 2015

Last Update Submit

September 15, 2016

Conditions

CachexiaLung Cancer

Keywords

Clarithromycin

Outcome Measures

Primary Outcomes (1)

  • Feasibility of a phase 3 study

    The number of patients recruited to the study as a measure of feasibility.

    1 year

Secondary Outcomes (9)

  • Tolerability of clarithromycin

    1 year

  • Safety of clarithromycin

    1 year

  • Safety of clarithromycin

    1 year

  • Effect of clarithromycin

    1 year

  • Effect of clarithromycin

    1 year

  • +4 more secondary outcomes

Study Arms (2)

Clarithromycin

ACTIVE COMPARATOR

Clarithromycin 250mg by mouth twice a day for 8 weeks

Drug: Clarithromycin

Placebo

PLACEBO COMPARATOR

Placebo matched capsule one capsule by mouth twice a day for 8 weeks

Drug: Placebo

Interventions

ClarithromycinDRUG
Clarithromycin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with stage IV, pathologically confirmed, NSCLC not suitable for/declining/not tolerating 1st/2nd-line palliative chemotherapy, or following completion of 1st/2nd-line palliative chemotherapy
  • A likely prognosis of ≥3 months.
  • Cachexia on the basis of any of the following, weight loss \>5% over past 6 months, or BMI \<20kg/m2 and weight loss \>2%, or appendicular skeletal muscle index determined by duel energy x-ray absorptiometry consistent with sarcopenia and weight loss \>2%.
  • Systemic inflammation on the basis of a C-reactive protein \>10mg/L.
  • Adequate renal function as defined by creatinine ≤132micromol/L and eGFR ≥30mL/min/1.73m2
  • Adequate liver function as defined by the following parameters, bilirubin ≤25micromol/L, and AST and ALT ≤2 times upper limit of normal, unless liver metastases, in which case ≤5 times upper limit of normal
  • Prepared to suspend, if necessary, the use of certain statins and/or substitute the use of domperidone for an alternative anti-emetic for the duration of the study

You may not qualify if:

  • ECOG Performance Status 3 or 4
  • Little or no food intake
  • Weight loss \>10% in 1 month or \>20% in total
  • Known hypersensitivity to clarithromycin
  • Inability to accurately measure QT interval, e.g. atrial fibrillation
  • QTc prolongation \>450 milliseconds in a male, or 470 milliseconds in a female
  • History of ventricular arrhythmia
  • Severe cardiac insufficiency (NYHA class \>2)
  • Untreated hypokalaemia/hypomagnesaemia
  • Active infection requiring antibiotics
  • Current or recent (within last 4 weeks) history of Clostridium difficile, eating disorder, dysphagia, malabsorption or diarrhoea
  • Untreated adrenal or thyroid diseases
  • Brain metastases
  • Use of corticosteroids/progestogens
  • Use of chemotherapy, other immunosuppressive, or antiviral (e.g. hepatitis C, HIV) drugs within 4 weeks
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CachexiaLung Neoplasms

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinnessRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Andrew Wilcock

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2015

First Posted

April 15, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

September 16, 2016

Record last verified: 2016-09